Description

Isoniazid & Pyridoxine Hydrochloride Tablets

(Isoniazid 300mg + Vitamin B6 10mg / 50mg)

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)

Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. is a specialized Manufacturer of Isoniazid and Pyridoxine Hydrochloride Tablets in India. This combination product addresses a critical challenge in Tuberculosis (TB) treatment. Isoniazid (INH) is the cornerstone first-line antibiotic for TB, but it depletes the body’s Vitamin B6 levels, leading to severe nerve damage (peripheral neuropathy). Our formulation combines the therapeutic power of Isoniazid with Pyridoxine (Vitamin B6) in a single tablet, ensuring patient compliance and preventing neurological side effects during the 6-month treatment course.

We offer Contract Manufacturing (Third Party) services for this essential public health drug. As a supplier to national TB control programs, our WHO-GMP certified facility in Mumbai utilizes advanced blending technologies to ensure the stability of the vitamin component alongside the antibiotic. Healthy Inc manages the export logistics, supplying government tenders, NGOs, and hospitals across Africa, the CIS region, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Protecting the cure, protecting the nerves.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Vitamin Stability: Pyridoxine is sensitive to light and moisture. We use specialized Light-Protective Coating and low-humidity manufacturing suites to prevent the vitamin from degrading, ensuring it remains effective throughout the shelf life.

  • Homogeneous Blending: The ratio of Isoniazid (300mg) to Pyridoxine (10mg) is 30:1. We use High-Shear Mixers and geometric dilution to ensure the small amount of vitamin is perfectly distributed in every tablet.

  • Dissolution Profiling: We engineer the tablet to release both drugs simultaneously, ensuring that as the antibiotic enters the bloodstream, the protective vitamin is right there with it.

• The Exporter: Healthy Inc

  • Program Kits: We can package these tablets as part of “TB Patient Kits” (containing Rifampicin, Pyrazinamide, Ethambutol) to support Directly Observed Treatment Short-course (DOTS) programs.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We confirm the potency of both active ingredients is strictly within label claim limits (90-110%).

• Impurity Control: We rigorously monitor for Free Hydrazine, a potential toxic impurity in Isoniazid, keeping it well below the strict international safety limits.

• Dissolution: Tested to ensure rapid release for immediate absorption.

5. Why Use Isoniazid + Pyridoxine?

The safe way to treat TB.

• Mechanism:

  • Isoniazid: It inhibits the synthesis of mycolic acids, an essential component of the bacterial cell wall of Mycobacterium tuberculosis. This kills the bacteria.

  • Pyridoxine: Isoniazid increases the excretion of Vitamin B6. A deficiency in B6 causes nerves to malfunction (tingling, numbness, burning pain). The added Pyridoxine replaces what is lost, preventing this damage.

• Key Indications:

  • Tuberculosis Treatment: First-line therapy (usually combined with other drugs).

  • Latent TB Infection: Prophylaxis (preventive therapy) to stop dormant TB from becoming active.

  • Neuropathy Prevention: Essential for patients with diabetes, malnutrition, HIV, or pregnancy undergoing TB treatment.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Isoniazid Pyridoxine Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Why is Vitamin B6 added?

  A: To save your nerves. Without it, Isoniazid can cause “Peripheral Neuropathy”—painful tingling and numbness in hands and feet. The vitamin prevents this.

• Q: Is it safe for the liver?

  A: Monitor closely. Isoniazid can cause liver damage (hepatotoxicity), especially in older patients or alcohol consumers. Regular liver tests are recommended.

• Q: Can I drink alcohol?

  A: NO. Alcohol significantly increases the risk of liver damage and reduces the effectiveness of the drug.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Active TB: 5mg/kg (usually 300mg) daily.

• Latent TB: 300mg daily for 6 to 9 months.

• Administration: Take on an empty stomach (1 hour before or 2 hours after meals) for best absorption.

9. Side Effects and Precautions

• Hepatic: Elevated liver enzymes, hepatitis (risk increases with age). symptoms include nausea, vomiting, yellow eyes/skin.

• Neurological: Peripheral neuropathy (burning/tingling) – Rare with this combination product.

• Gastrointestinal: Nausea, vomiting.

• Interaction: Isoniazid increases levels of Phenytoin and Carbamazepine. Foods high in tyramine (aged cheese, cured meats) can cause high blood pressure reactions.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light and moisture.